Sr. Regulatory Specialist

Overview

BD is one of the largest global medical technology companies. The Senior Regulatory Affairs Specialist for Urology and Critical Care (UCC) is responsible for preparation of U.S. and CE marking submissions/registration activities, and supporting registrations in other regions. The role involves cross-functional collaboration to develop regulatory strategy across the product lifecycle. On-site requirement: four days per week in Covington with remote work on Fridays.

To be successful, you will apply written and analytical skills to create technical documents, cover design changes and change notifications for BD’s medical devices, and communicate effectively with internal customers, team members, and external auditors.

• Lead regulatory strategy and lifecycle support for product project teams, including change controls, timelines, and submission document review.
• Prepare and maintain STED technical files to support CE marking and ensure EU MDR compliance, including interactions with notified bodies.
• Provide regulatory guidance for post-market activities such as remediation actions and labeling updates.
• Lead and support U.S., EU, and international submissions, including NPD initiatives and change assessments.
• Drive process improvements, mentor team members, and support audits, regulatory inspections, and cross-functional initiatives (e.g., Kaizen events).

• Bachelor’s degree required, preferably in a scientific discipline or regulated industry; ability to travel up to 15% as needed.
• Experience authoring and supporting U.S. (510(k)), EU (Tech File/STED), and international regulatory submissions.
• Proven ability to update and maintain STED files for CE marking and support notified body interactions under EU MDR.
• Strong knowledge of U.S. and European medical device regulations, including familiarity with IEC 60601 standards and post-market regulatory requirements.
• Demonstrated ability to manage multiple projects, maintain strict confidentiality, and provide regulatory strategy, labeling review, and post-market guidance.

• 4–7 years of experience in medical devices; experience in product registration, new product development, and product changes preferred.
• Regulatory Affairs Certification (RAC) preferred.
• Ability to provide regulatory support through the product life cycle on project teams (e.g., regulatory strategies, change control assessments, timelines, and submission document reviews).
• Ability to work in a fast-paced and complex environment with multiple priorities; self-motivated and able to take ownership.
• Strong technical writing skills and proficiency in compiling successful submissions.

At BD, we prioritize on-site collaboration to foster creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, a minimum of four days in-office presence per week is typical, with flexibility where applicable. Remote or field-based positions will indicate arrangements in the job posting. Employment may be contingent on proof of full vaccination against COVID-19 where required by local law.

In some locations, COVID-19 testing may be available or required. BD’s Workplace Accommodations Policy is applied in accordance with applicable law. This section reflects the company’s commitment to equal opportunity in hiring.

To find purpose in the possibilities, join a culture that supports learning, growth, and collaboration. BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.